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Early and Comprehensive Care Bundle in Elderly for Acute Heart Failure: a Stepped Wedge Cluster Randomized Trial (ELISABETH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03683212
Recruitment Status : Completed
First Posted : September 25, 2018
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
This is a prospective multicentre (N=15), stepped-wedge randomized trial that aims to evaluate the benefit of a protocolised comprehensive care bundle for early management of acute heart failure in the ED.

Condition or disease Intervention/treatment Phase
Acute Heart Failure Procedure: Early intensive care bundle Not Applicable

Detailed Description:

Acute heart failure (AHF) is one of the most common diagnoses for elderly patients in the emergency department (ED), with an admission rate higher than 80% and 1-month mortality around 10%. There is scarce evidence of any clinical added value of a specific treatment to improve outcomes, and European guidelines for the management of AHF are based on moderate levels of evidence, due to the lack of randomized controlled trials. Recent reports suggest that the very early administration of full recommended therapy may decrease mortality. However, several studies highlighted that elderly patients often received suboptimal treatment: For example, less than a third of them received nitrates therapy while it is recommended. Furthermore, a recent preliminary study reported that only 50% of them are assessed for precipitating factors - although it has been reported that precipitating factors are independently associated with mortality.

The hypothesis of the Elisabeth Study s is that an early care bundle that comprises early and comprehensive management of symptoms, along with prompt detection and treatment of precipitating factors should improve AHF outcome in elderly patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 503 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early and Comprehensive Care Bundle in Elderly for Acute Heart Failure: a Stepped Wedge Cluster Randomized Trial
Actual Study Start Date : December 10, 2018
Actual Primary Completion Date : November 12, 2019
Actual Study Completion Date : November 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Intervention period : early and comprehensive care bundle Procedure: Early intensive care bundle

The care bundle comprises a list of items to follow and tick on a handover checklist within 4 hours of ED management:

  1. Treatment of the congestion: (international guidelines and recommendations)
  2. Treatment of precipitating factors
  3. NIV (non-invasive ventilation) if respiratory distress with hypercapnia and pH < 7.35 in absence of contra indication.
  4. Preventive LMWH (low molecular weight heparin) if no pre-existing anticoagulation therapy.

No Intervention: acute heart failure standard therapy



Primary Outcome Measures :
  1. Number of days alive and out of hospital [ Time Frame: 30 days ]
    Number of days alive and out of hospital


Secondary Outcome Measures :
  1. To evaluate the effect of AHF management on the 30-day cardiovascular death [ Time Frame: 30 days ]
    cardiovascular death

  2. To evaluate the effect of AHF management on the 30-day all causes death [ Time Frame: 30 days ]
    all causes death

  3. To evaluate the effect of AHF management on the hospital readmission at 30 days [ Time Frame: 30 days ]
    hospital readmission

  4. To evaluate the effect of AHF management on the length of stay in hospital [ Time Frame: 30 days ]
    length of stay in hospital

  5. To evaluate the effect of AHF management on changes of more than 2 fold in creatinine level from randomization to day 30 or to discharge whichever comes first [ Time Frame: 30 days ]
    creatinine level



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 75 years and older admitted to the emergency department with a diagnosis of acute heart failure determined by the emergency physician, based on the presence of:

    • at least one of the following symptoms : acute, or worsening of dyspnea, orthopnea
    • one or more of the followings: pulmonary rales, peripheral edema, a chest radiograph or transthoracic echocardiography showing pulmonary vascular congestion signs, increased natriuretic peptides (BNP or NT-pro-BNP).
    • Patients affiliated to French social security ("AME excepted")
    • Written informed consent signed by the patient / the trustworthy person / family member / close relative, or inclusion in case of emergency and written informed consent will been signed by the patient (if need be by trustworthy person, family member or close relative) as soon as possible (article L1122-1-2 of the French Public Health Code)

Exclusion Criteria:

  • Patients are excluded if they have any of the followings:

    • other obvious cause of acute illness (severe sepsis, ST elevation Myocardial infarction)
    • systolic blood pressure less than 100 mmHg
    • severe mitral or aortic stenosis, or severe aortic regurgitation
    • known chronic kidney injury on dialysis
    • shock from any cause
    • Time from ED entrance to inclusion > 6h
  • Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683212


Locations
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France
Emergency department Hospital Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Yonathan Freund, Doctor Assistance Publique - Hôpitaux de Paris
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03683212    
Other Study ID Numbers: K170918J
2018-A01139-46 ( Other Identifier: ANSM )
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Emergency department
Elderly
Acute heart failure
Pulmonary edema
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases